Quick Facts at a Glance
- Recall Date
- March 5, 2026
- Hazard Level
- HIGH
- Brand
- Cook
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Cook
- Product type
- Central Venous Catheter Set
- Model numbers
- Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260424(10)15569919, Lot Number 15569919, UDI (01)00827002439832(17)260403(10)15520378, Lot Number 15520378, UDI (01)00827002439832(17)260227(10)15487727, Lot Number 15487727, UDI (01)00827002439832(17)260227(10)15484947 +6 more
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 5, 2026
Reported by FDA DEVICE
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cook Incorporated or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
Spectrum Central Venous Catheter Sets are used for vascular access in critical care, delivering medications and fluids to patients. They come in multiple configurations to fit different patient needs.
Why This Is Dangerous
Labels showing expiration dates beyond true shelf life could misrepresent product validity and potentially affect device integrity.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall primarily affects healthcare facilities and patients who may be using mislabeled expiration data. It requires facility-level action to verify lots and arrange replacements or disposal.
Practical Guidance
How to identify if yours is affected
- Review recall notice for affected reference part numbers and lots.
- Check UDI codes and lot numbers on the device packaging.
- Compare with your facility inventory list.
Where to find product info
UDI (01) embedded in product labeling and lot numbers on packaging
What timeline to expect
Replacement or remediation timelines vary by facility; expect several weeks to months depending on supply.
If the manufacturer is unresponsive
- Escalate to hospital procurement or risk management.
- File FDA inquiries if manufacturers are unresponsive.
How to prevent similar issues
- Implement strict labeling verification at receiving and shelf-life audits.
- Maintain updated supplier recall contacts and UDI databases.
Documentation advice
Document lot numbers, UDIs, dates, and communication with providers and manufacturers.
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Product Details
Recall pertains to Spectrum Central Venous Catheter Sets with multiple reference part numbers and order numbers listed in the recall notice. Affected lots include various UDI codes and lot numbers such as Lot 15569919, 15520378, 15487727, 15484947, 16617145, NS16617419, and NS16617420. Distribution is worldwide.
Reported Incidents
No specific injuries or adverse events are reported in the provided recall data.
Key Facts
- Multiple reference part numbers and orders affected
- Expiration dates labeled exceed true shelf life
- High hazard level
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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